The following data is part of a premarket notification filed by Boditech Med Inc. with the FDA for Afias Tsh-sp, Afias Tsh-vb, Afias-6/sp Analyzer, Afias-6/vb Analyzer.
| Device ID | K170232 |
| 510k Number | K170232 |
| Device Name: | AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | BODITECH MED INC. 43, GEODUDANJI 1-GIL, DONGNAE-MYEON Chuncheon-si, KR |
| Contact | Hyung-ju Oh |
| Correspondent | Hyung-ju Oh BODITECH MED INC. 43, GEODUDANJI 1-GIL, DONGNAE-MYEON Chuncheon-si, KR |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-25 |
| Decision Date | 2017-10-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886133010075 | K170232 | 000 |
| 08806133010075 | K170232 | 000 |
| 08806133005279 | K170232 | 000 |
| 08806133005262 | K170232 | 000 |